- VENCLEXTA plus obinutuzumab is a combination, fixed duration
therapy for previously untreated patients with CLL who are unfit
- VENCLEXTA was developed out of the
Australian discovery that a protein called BCL-2 helps CLL cells
survive. Blocking this protein helps to kill and reduce the number
of these cancer cells1,2,3
Over 1,800 people are predicted to be diagnosed with CLL in
Australia this year making it the most common type of leukaemia
diagnosed in Australia4
Tuesday 1 December 2020, Sydney – AbbVie (NYSE: ABBV) Australia
has welcomed the Government’s announcement that Venclexta®
(venetoclax) in combination with obinutuzumab will be available to
eligible Australians with Chronic Lymphocytic Leukaemia (CLL) as a
first line therapy via the Pharmaceutical Benefits Scheme (PBS) from
the 1st December 2020. This PBS listing will allow CLL
patients who cannot be treated with standard chemotherapy-based
treatments to have affordable access to this first line combination treatment.
Venclexta in combination with obinutuzumab is a targeted, 12-month
duration treatment that is to be reimbursed for patients with
previously untreated CLL, who are unfit for conventional chemotherapy.1,5
Venclexta works by blocking a protein in the body (BCL-2) that helps
these cancer cells survive. Blocking this protein helps to kill and
reduce the number of cancer cells. It is an oral tablet that can be
taken daily in combination with intravenous obinutuzumab.1
The Government’s reimbursement of this combination as a first-line
treatment reflects the continued effort to expand access to the range
of targeted cancer treatments available to patients with blood cancer.
According to Professor Stephen Opat, Director of Clinical
Haematology at Monash Health Haematology, this PBS listing widens
access to affordable treatment for eligible CLL patients who cannot be
treated with conventional chemo-based therapies.
“Historically chemotherapy has been the most common starting point
to treat blood cancer, but unfortunately there are several patients
that are unfit or can’t tolerate these agents due to side effects.
Expanding the list of available treatments, especially targeted
therapies, is now the focus area for healthcare. The Government’s
commitment to improve access to innovative medicines means clinicians
can now explore a range of options for patients,” said Professor Opat.
Venclexta was developed as part of a research collaboration between
AbbVie, Genentech, a member of the Roche Group of Companies, and the
Walter and Eliza Hall Institute in Melbourne, Australia.3
Professor John Seymour, MBBS, Director of Clinical Haematology at
the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, says
the new listing for the locally discovered treatment is a positive
development for cancer patients.
“This reimbursement represents another important milestone for
Australia. Venclexta is the result of 30 years of research and
collaboration. It is positive to see that this home grown discovery
has now evolved into a medicine that more Australians can have funded
access to,” said Professor Seymour.
Chris Stemple, General Manager at AbbVie Australia, commended the
Government’s move to fund Venclexta in combination with obinutuzumab.
“We are proud that from today, eligible Australians with CLL will
have reimbursed access to Venclexta earlier in their treatment cycle.
Its listing reflects a change towards earlier use of targeted
medicines in the treatment of CLL. We hope this paves the way for
continued innovation of first-line therapies, not only in blood cancer
but for other types of cancer,” said Mr Stemple.
VENCLEXTA® is a prescription medicine
used to treat adults with Chronic Lymphocytic Leukaemia (CLL) or small
lymphocytic lymphoma (SLL), conditions where the blood and bone marrow
or lymph nodes contain too many of a type of white blood cells. The
active substance in this medicine is called venetoclax.
VENCLEXTA in combination with rituximab is indicated for the
treatment of adult patients with chronic lymphocytic leukaemia (CLL)
who have received at least one prior therapy.
VENCLEXTA monotherapy is indicated for the treatment of:
- patients with relapsed or refractory CLL with 17p deletion,
- patients with relapsed or refractory CLL for whom there
are no other suitable treatment options.
VENCLEXTA in combination with obinutuzumab will be listed on the PBS
from the 1st December 2020 for the treatment of eligible
patients with CLL or small lymphocytic leukaemia (SLL) as a first line
therapy who are considered unfit or unsuitable for chemo-immunotherapy1,5.
All medicines have risks and benefits and may impact people in
different ways. Refer to the Consumer Medicines Information (CMI)
which can be located at https://medicines.org.au/c/view/vecvenclCMI and
your doctor for further information about VENCLEXTA.
(venetoclax) Safety Inform1
Venclexta has risks and benefits. You must not take
it if you are allergic to venetoclax or to any of the inactive
ingredients. Do not take Venclexta if you are taking any of the
following medicines, including: medicines used to treat or prevent
fungal infections, including ketoconazole, posaconazole, voriconazole,
itraconazole; clarithromycin (an antibiotic); conivaptan (a medicine
used to treat low sodium levels); medicines used to treat HIV or
hepatitis C, including ritonavir, indinavir or lopinavir. Do not drink
grapefruit juice, or eat grapefruit, starfruit or Seville oranges or
marmalades. Do not give Venclexta to children and adolescents under 18
years of age. Do not take Venclexta if you are pregnant or plan to
become pregnant, or if you are breastfeeding or plan to breastfeed. If
you are a woman of child-bearing age, you must use a highly effective
form of contraception during treatment with Venclexta and for at least
30 days after your last dose. Tell your doctor, nurse or pharmacist if
you have or have had heart, kidney or liver problems. Tell your doctor
if you recently received or are scheduled for any vaccinations. Do not
stop using Venclexta or change the dose without checking with your doctor.
Venclexta can cause tumour lysis syndrome, which is caused by
the fast breakdown of cancer cells. Tumour lysis syndrome, which can
be fatal, has occurred rarely in patients receiving Venclexta. To help
prevent this side effect it is important to follow all your doctor’s
instructions carefully, especially when you start treatment with
Venclexta and make sure you drink plenty of water (6 to 8 glasses or
1.5 to 2 L per day) as instructed throughout your treatment and every
time your dose is increased. Tell your doctor immediately if you
experience, especially at the beginning of treatment, symptoms such
as: fever or chills, feeling sick or vomiting, being short of breath,
changes in your heart rate, feeling unusually tired, dark or cloudy
urine, joint or muscle pain, feeling confused, convulsions or fits.
Ensure you follow all your doctor’s instructions carefully and keep
all your appointments, including those for blood tests. You may
experience a low number of neutrophils, a type of white blood cells –
this can be severe and need treatment. Your doctor will check your
blood counts during treatment with Venclexta. You may experience
infections during treatment with Venclexta. Some infections can be
very serious or even fatal. Your doctor will closely monitor and treat
you right away if you have fever or any signs of infection during
treatment with Venclexta. Tell your doctor immediately if you have
signs of an infection before or while taking Venclexta, including
fever or chills; feeling weak or confused; cough, runny nose, sore
throat; congestion on the chest; or pain or burning feeling when
passing urine. Some of the less serious side effects of Venclexta
include: diarrhoea, tummy pain, constipation, nausea (feeling sick),
vomiting, reduced appetite, swelling of the arms, legs and feet,
looking pale, feeling tired, having little or no energy, shortness of
breath when exercising, feeling dizzy, headache, trouble sleeping.
Tell your doctor or pharmacist if you notice anything else that is
making you feel unwell. Some medicines and Venclexta may interfere
with each other, so tell your doctor if you are taking medicines
containing any of the following (refer also to the list of medicines
above): fluconazole, ciprofloxacin, erythromycin, azithromycin,
nafcillin, rifampicin, carbamazepine, phenytoin, efavirenz,
etravirine, captopril, carvedilol, felodipine, bosentan, verapamil,
diltiazem, modafinil, St John’s wort (Hypericum perforatum), warfarin,
amiodarone, ticagrelor, digoxin, dronedarone, quinidine, ciclosporin,
quercertin, ranolazine, everolimus and sirolimus. Tell your doctor or
pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop. Tell any other
doctors, pharmacists, dentists, or surgeons treating you that you are
taking Venclexta, and remind them before you start any new medicines.
If you have any questions about using Venclexta, including its risk
and benefits, how much to use, how and when to use it, ask your
healthcare professional and refer to the Consumer Medicine
Information. The Consumer Medicine Information is available from your
pharmacist, by calling AbbVie Pty Ltd on 1800 043 460 or here: https://medicines.org.au/c/view/vecvenclCMI
Healthcare Professionals should review the full Product Information
for further details and before prescribing. The Product Information is
available by calling AbbVie Pty Ltd on 1800 043 460 or here: https://medicines.org.au/i/view/vepvenclPI
About AbbVie in Australia
AbbVie is a global, research-driven biopharmaceutical company
committed to developing innovative advanced therapies for some of the
world’s most complex and critical conditions. Our heritage in
Australia reaches back more than 75 years and we employ more than 320
people with our therapies currently benefiting more than 40,000
Australians. The company’s mission is to use its expertise, dedicated
people and unique approach to innovation to markedly improve
treatments. Recently, we acquired Allergan which immediately
diversified our business across several therapeutic areas: Immunology,
Hematologic Oncology, Neuroscience and Allergan Aesthetics.
Our commitment to making a remarkable impact doesn’t end at
developing medicines; it begins there. We provide broader support to
our patients and help address the health needs of underserved
communities. We strive to protect our environment and to make a
positive impact in the areas where we live and work.
For further information please visit http://www.abbvie.com.au. Follow @abbvie_AU or
follow us on Facebook or our LinkedIn page.